ANAHEIM, Calif.—PolyOne Corp. is out with a new medical grade of thermoplastic elastomer in response to shortages of siloxane, a key ingredient of silicone, and the closure of some large-scale sterilization facilities.
The Avon Lake, Ohio-based compounder and concentrate maker launched a new formulation of Versaflex—called HCBT218—at the Medical Design & Manufacturing West expo in Anaheim, with the focus of easing supply problems.
The siloxane supply has been constrained since 2017 by environmental regulations, particularly in China, work stoppages due to mechanical breakdowns and complete shutdowns. Producers also have been slow to add capacity.
Last year, the U.S. Food and Drug Administration issued several warnings about shortages of medical tubing and devices after some sterilization facilities were closed for emitting unsafe levels of ethylene oxide, which is a carcinogen, into the air around their sites.
These constraints have led to higher prices, longer lead times and increased interest in silicone alternatives.
"People are asking: 'Do I really need silicone?' For a lot of applications, we're finding they don't," said Russell Danielson, PolyOne's senior marketing manager. "Silicone is great if you need a high level of really low compression set or very high temperature resistance, but it is essentially over-engineered for a lot of uses."
In response to supply and sterilization issues, Danielson said PolyOne formulated a new kind of Versaflex TPE for biopharmaceutical tubing applications that offers weldability, kink resistance and tensile strength performance comparable to leading medical tubing materials, including silicone and TPEs.
The new grade of Versaflex can be utilized for most medical tubing applications, such as peristaltic pumps, IV drug delivery, infusion pumps and other applications that involve moving pharmaceuticals between bags, bottles and patients. However, it was developed specifically to address the needs of the biopharmaceutical manufacturing process, in which fluids must be transported from one bioreactor to another during drug development and processing.
Just ahead of the product launch, Jim Mattey, PolyOne's global marketing director of specialty engineered materials, said the expanded Versaflex line allows customers to innovate and meet market needs.
"We are committed to leveraging our material science expertise to formulate alternative and customized solutions that meet regulatory demands and functional necessity for lifesaving medical devices, especially in the face of market uncertainties," Mattey said.
Supply chain concerns
The FDA is monitoring closely the supply chain effects of closures and potential closures of facilities that use ethylene oxide to remove potentially harmful germs and other microorganisms prior to use.
The agency said it is concerned about the future availability of sterile medical devices and the potential shortages that might impact patient care.
More than 20 billion devices sold in the U.S. every year are sterilized with ethylene oxide, accounting for about 50 percent of devices that require sterilization, according to the FDA.
The medical device industry, FDA, U.S. Environmental Protection Agency and state authorities have been at odds about how to balance production needs and environmental impacts of ethylene oxide sterilization facilities.
The spokesman for the Advanced Medical Technology Association—known as AdvaMed—on Feb. 18 urged the Environmental Protection Agency to abandon EtO risk assessment value for one that is more feasible, based on the best available science, and one that will not endanger public health by threatening the availability of needed medical technologies.
"Anyone studying this issue can see that the EPA standard is impractical and does not meet the definition of good science," said Scott Whitaker, AdvaMed president and CEO. "The medical technology industry is committed to the safe and responsible use of EtO, even as we look for alternatives and ways to reduce EtO emissions. However, the EPA's risk standard sets an unreasonable threshold that will only threaten the continued availability of tens of billions of the EtO-sterilized medical technologies patients depend on."
Closures add up
The most recent closure was scheduled to occur by the end of 2019 at a Viant Medical sterilization operations in Grand Rapids, Mich., according to the company's consent order with the state of Michigan.
Another closure happened Dec. 13 at a Medline Industries facility in Waukegan, Ill. This was a voluntary stop in operations to install emissions reduction equipment to bring the facility in line with ethylene oxide exposure standards Illinois approved last year, the FDA said.
Before that, in October 2019, the Georgia State Attorney General requested the potential closure of a Becton Dickinson and Co. medical device sterilization facility in Covington, Ga., because of emissions. If it were to be closed, the FDA is concerned that significant additional strains to the supply chain for critical medical devices may lead to shortages of surgical kits, feeding tubes and a variety of catheters.
Also in October 2019, the FDA said it learned a Sterigenics contract sterilization facility in Willowbrook, Ill., will not reopen after closing in February, while the company's facility in Atlanta temporarily remains closed for construction work to reduce ethylene oxide emissions.
Meeting market needs
PolyOne was able to commercialize its new grade of Versaflex in about nine months to meet demand for materials that can be sterilized with alternative methods.
"There was pull from our customers to develop a new solution and we were able to move quickly," Danielson said. "Everything was lined up. The market was looking for something new, we had competency in this area from previous products, and we were able to put that all together with one of our key customers to mature the solution."
To address another concern, PolyOne's health care formulations have no beeswax or animal-derived products such as bone-based additives.
The new grade of Versaflex is commercially available in the U.S., as PolyOne awaits biocompatibility certifications for hemocompatibility, cytotoxicity, systemic toxicity and Class VI.
The tubing compound is being manufactured in McHenry, Ill. PolyOne officials said as demand grows globally, the company can add production at other facilities.
PolyOne operates 61 manufacturing sites and eight distribution facilities in North America, South America, Europe and Asia, with 5,600 employees. The company posted sales of $2.9 billion in 2019.